Prostate Cancer RecurrentPhase 4FITNCT01512472
Firmagon (Degarelix) Intermittent Therapy
A Phase 4 study testing degarelix in people with Prostate Cancer Recurrent, run by Canadian Urology Research Consortium at 15 sites in Canada.
Trial summary
Men with localized prostate cancer requiring intermittent androgen deprivation therapy for biochemical recurrence following radical therapy will be asked to participate in a phase 4 safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix (Firmagon®) therapy with the endpoint of prolonging… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- degarelix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 15 sitesCanada
- Study dates
- Jan 2012to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated
- PSA level meeting both of these criteria:
- PSA level of ≥ 5 ng/mL.
- For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir.
- screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/mL.
Who cannot join
- Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation)
- Has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Recherches Clinique /Clinical Research
Granby, Quebec, J2G 8Z9
Northeast Cancer Centre, Health Sciences North
Greater Sudbury, Ontario, P3E 5J1
Centre of Clinical Research
Halifax, Nova Scotia, B3H 1V7
McMaster Institute of Urology
Hamilton, Ontario, L8N 4A6
Centre of Applied Urological Research / Kingston General Hospital
Kingston, Ontario, K7L 3J7
London Health Sciences Centre
London, Ontario, N6A 5W9
The Urology Specialists / Les Urologues Specialises
Montreal, Quebec, H2X 1N8
MUHC Montreal General Hospital
Montreal, Quebec, H3G 1A4
URLX Corporation
Ottawa, Ontario, K1H 1A2
Ultra-Med Research
Pointe-Claire, Quebec, H9R 4S3
Centre de recherche du CHUQ-L'hotel-Dieu de Quebec
Québec, Quebec, G1R 3S1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network
Toronto, Ontario, M5G 2M9
The Prostate Centre
Vancouver, British Columbia, V6Z 3J5
Manitoba Prostate Centre
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: Randomized, Multicentre Efficacy and Safety Study Comparing 10 Mons vs 4 Mons Degarelix Therapy in Prolonging the Off Treatment Interval in Men With Localized Prostate Cancer Receiving Intermittent ADT for Biochemical Recurrence Following Radical Local Therapy
Men with localized prostate cancer requiring intermittent androgen deprivation therapy for biochemical recurrence following radical therapy will be asked to participate in a phase 4 safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.
Read the detailed description
This is an open-label, multi-centre, randomised trial with subjects receiving subcutaneous (s.c.) monthly injections of degarelix depot. All patients will be treated with a one-month starting dose of 240mg on Day 0. Subjects are then randomized to receive either nine or three maintenance doses of one month duration. The primary objective is to determine the effect of degarelix therapy on the length of the off treatment interval (defined as serum Prostate-specific antigen (PSA) increasing to 5 ng/ml) following completion of the androgen deprivation therapy. The trial will also assess the effect of degarelix therapy on PSA kinetics (specifically PSA doubling time), PSA nadir, and effect on quality of life as well as other measures. The efficacy and safety of these two treatments will also be reported.
- Conditions
- Prostate Cancer Recurrent
- Being tested
- degarelix
- Keywords
- localized prostate cancer, degarelix, intermittent androgen deprivation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
degarelixDrug
Starting dose of 240 mg (40 mg/mL; injection volume 2 x 3 mL; s.c.) degarelix one-month depot will be administered sc on Day 0, followed by a maintenance dose of 80 mg (20 mg/mL; injection volume 1 x 4 mL; s.c.) sc degarelix one-month depot will be administered into the anterior abdominal wall on Month 1, 2, 3, 4, 5, 6, 7, 8 and 9 for the 10 month arm and month 1, 2 and 3 for the 4 month arm.
| Study group | Role | What they receive |
|---|---|---|
| 10 month degarelix therapy | Active comparator | Not described Receives: Drug: degarelix |
| 4 month degarelix therapy arm | Active comparator | Not described Receives: Drug: degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum PSA
The study will compare the length of the off treatment interval (in months) of subjects in the 4 month arm vs those in the 10 month arm. The off treatment interval is defined as the time from PSA nadir following completion of hormone therapy in both arms until the time PSA reaches 5.0ng/ml
Measured: approximately 15 months
Secondary outcomes (1)
serum PSA
PSA nadir is described as the serum PSA value after the completion of either 4 months or 10 months of therapy.
Measured: at 4 months (4 mon arm) or 10 montths (10 mon arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: acrrual target was not being met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Urology Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Laurence Klotz, MD, Principal investigator, Canadian Urology Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512472
- Sponsor's protocol ID
- CURC - FIT-0002
- Acronym
- FIT
- Status last verified
- Sep 2019
- First submitted
- 10 Nov 2011
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicentre Efficacy and Safety Study Comparing 10 Mons vs 4 Mons Degarelix Therapy in Prolonging the Off Treatment Interval in Men With Localized Prostate Cancer Receiving Intermittent ADT for Biochemical Recurrence Following Radical Local Therapy
- ClinicalTrials.gov ID
- NCT01512472
- Acronym / sponsor ID
- FIT / CURC - FIT-0002
- Conditions
- Prostate Cancer Recurrent
- Keywords
- localized prostate cancer, degarelix, intermittent androgen deprivation therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: acrrual target was not being met
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Canadian Urology Research ConsortiumUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Jan 2012
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Men with localized prostate cancer requiring intermittent androgen deprivation therapy for biochemical recurrence following radical therapy will be asked to participate in a phase 4 safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.
Detailed description
This is an open-label, multi-centre, randomised trial with subjects receiving subcutaneous (s.c.) monthly injections of degarelix depot. All patients will be treated with a one-month starting dose of 240mg on Day 0. Subjects are then randomized to receive either nine or three maintenance doses of one month duration. The primary objective is to determine the effect of degarelix therapy on the length of the off treatment interval (defined as serum Prostate-specific antigen (PSA) increasing to 5 ng/ml) following completion of the androgen deprivation therapy. The trial will also assess the effect of degarelix therapy on PSA kinetics (specifically PSA doubling time), PSA nadir, and effect on quality of life as well as other measures. The efficacy and safety of these two treatments will also be reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 month degarelix therapy | Active comparator | Drug: degarelix |
| 4 month degarelix therapy arm | Active comparator | Drug: degarelix |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated
- PSA level meeting both of these criteria:
- PSA level of ≥ 5 ng/mL.
- For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir.
- screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/mL.
Key exclusion criteria (2 listed)
- Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation)
- Has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| degarelixStarting dose of 240 mg (40 mg/mL; injection volume 2 x 3 mL; s.c.) degarelix one-month depot will be administered sc on Day 0, followed by a maintenance dose of 80 mg (20 mg/mL; injection volume 1 x 4 mL; s.c.) sc degarelix one-month depot will be administered into the anterior abdominal wall on Month 1, 2, 3, 4, 5, 6, 7, 8 and 9 for the 10 month arm and month 1, 2 and 3 for the 4 month arm. | Drug | 10 month degarelix therapy, 4 month degarelix therapy arm |
Primary outcome
serum PSA
Time frame: approximately 15 months
The study will compare the length of the off treatment interval (in months) of subjects in the 4 month arm vs those in the 10 month arm. The off treatment interval is defined as the time from PSA nadir following completion of hormone therapy in both arms until the time PSA reaches 5.0ng/ml
1 secondary outcome
serum PSA
Time frame: at 4 months (4 mon arm) or 10 montths (10 mon arm)
Results and safety
The study was stopped early (reason given: acrrual target was not being met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Klotz, MD principal investigator
Canadian Urology Research Consortium
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing degarelix in people with Prostate Cancer Recurrent, run by Canadian Urology Research Consortium at 15 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: acrrual target was not being met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum PSA (time frame: approximately 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.